Nigerian Journal of Plastic Surgery

ORIGINAL ARTICLE
Year
: 2020  |  Volume : 16  |  Issue : 2  |  Page : 51--60

A prospective randomized comparative study of facial scar modulation using topical silicone gel versus coconut oil


Vipin V Nair, Jerry R John, Ramesh Kumar Sharma 
 Department of Plastic Surgery, PGIMER, Chandigarh, India

Correspondence Address:
Dr. Vipin V Nair
Department of Surgery, Armed Forces Medical College, Pune, PIN 411 040
India

Abstract

Context: Scar following facial trauma is an important problem affecting aesthetics and function. Aim: The aim of the study is to compare the usefulness of topical silicone gel versus coconut oil in facial scar modulation. Design: Prospective randomized comparative study was done between January and December 2016. Subjects and Methods: Seventy-four post-traumatic facial scar patients were randomized into three groups − Group A topical silicone gel only, Group B coconut oil only, and Group C both. Observational data were collected and photographs were taken at 2 weeks, 1 month, 3 months, and 6 months. Vancouver scar score and visual analog scale score were done for observational data. Photographs were analyzed by two independent blind observers at the end of the study. Results: Topical silicone gel gave superior results in reducing vascularity and pliability at 1 month and hyperpigmentation at 3 months. Coconut oil has better antipruritic effects at 1 month as compared topical silicone gel. Conclusions: Topical silicone gel is a superior product for initial management of facial scars compared to coconut oil.



How to cite this article:
Nair VV, John JR, Sharma RK. A prospective randomized comparative study of facial scar modulation using topical silicone gel versus coconut oil.Nigerian J Plast Surg 2020;16:51-60


How to cite this URL:
Nair VV, John JR, Sharma RK. A prospective randomized comparative study of facial scar modulation using topical silicone gel versus coconut oil. Nigerian J Plast Surg [serial online] 2020 [cited 2021 Mar 3 ];16:51-60
Available from: https://www.njps.org/text.asp?2020/16/2/51/303832


Full Text



Key Message: Topical silicone gel is a superior product for initial facial scar modulation.

 INTRODUCTION



Scars following facial trauma are an important cosmetic problem and is a silent morbidity faced by many persons in our society. These scars are associated with evil persons and social outcast in many of our fiction and stories of mythologies. Because of these associations ascribed to them by the society, persons harboring such facial scars are under tremendous mental agony. These people will never get a positive role in print or digital media. They will also be made fun of by others in the society. This leads to depression and other mental problems in these individuals. Aesthetics apart, facial scars also affect the muscles of facial expression. Some scars can be painful or itchy.

Most available studies are published for the treatment of established scars.[1],[2],[3],[4] Many consider silicone gel sheet as the gold standard for scar reduction.[5] Topical silicone gel is a method of using silicone polymer for scar modulation. These formulations reduce the common problems of silicone gel sheet as fixing over joints, cavities, and on exposed areas like face is cumbersome and impractical. This long chain silicone polymer fluid dries up and forms a flexible, transparent, gas permeable, and water impermeable silicone sheet as described by Monstrey et al.[6] Kim et al.[7] found that the application of the gel was comparable to the gel sheet.

In India, coconut oil is traditionally advised as a home remedy for scar improvement. As described by Durgaprasad and Srivastava,[8] coconut oil consists of 44.6% lauric acid, 16.8% myristic acid, and 8.2% palmitic acid. Skin is permeable to coconut oil. The scar modifying properties of coconut oil is believed to be due to the presence of capric acid, caprylic acid, lauric acid, and vitamin E. Lauric acid is converted to monolaurin and capric acid is converted to monocaprin in vivo. These products have antibacterial, antifungal, and antiviral properties. Coconut oil is recommended to decrease postpartum stria marks on the abdomen.[9],[10]

Both silicone and coconut oil are easy to apply and require no bandaging. Studies evaluating the efficacy of silicone gel are less in the existing literature. Hence, we endeavored to identify which one is better of the management options between topical silicone gel and coconut oil.

 MATERIALS AND METHODS



This study was conducted from January to December 2016 in a tertiary care plastic surgery trauma center in North India. We framed the null hypothesis as the use of topical silicone gel is not superior to coconut oil or a combination of silicone gel and coconut oil in post-traumatic scar modulation. All patients of post-traumatic facial scar presenting within the first 2 weeks of wound healing were included. After taking consent and ethical committee approval, patients were enrolled. The exclusion criteria were children less than 12 years, age more than 60 years, late presentation, pregnant ladies, patients with metabolic disorders, and abnormal scar formers.

The patients were randomized using computer generated randomization method and assigned to three groups. Group A applied topical silicone gel (Hexilak Ultra™, Menarini Inc) twice daily and massaged for 3 minutes each time for 6 months. Group B used virgin coconut oil (Organic India™) over the scar twice daily and massaged for 3 minutes each time for 6 months. Group C applied coconut oil and massaged for 3 minutes in the morning and topical silicone gel for 3 minutes in night for 6 months. The first baseline evaluation was done at 2 weeks after the wound has healed and suture removed. No medications were used for scar modulation at this time. After the first baseline photograph, the therapy is initiated as per group status.

Photographs were taken at the beginning of the study for baseline documentation at 2 weeks and on three subsequent occasions thereafter, that is, 1 month, 3 months, and 6 months. The images were obtained under uniform lighting at a fixed distance with a light blue background. A high definition digital camera was used without flash. The size of the scar in terms of length, breadth, and height was noted on all visits. Color and consistency were also noted at each visit. The scar color was classified as same, lighter, or darker compared to the surrounding skin. The consistency was documented as similar or harder to the surrounding skin. Vancouver scar scoring (VSS) was used for noting the scar characters of vascularity, pliability, pigmentation, and height.[11],[12],[13] Apart from this, any symptoms of pain and pruritus were noted. Pain and pruritus were analyzed as per the subjective problem of the patient and recorded using the visual analog scale (VAsS) at each visit. Pain and pruritus (VAS) were recorded on a scale from 1 to 10 (1 = no symptom; 10 = severe symptoms).

The photographs were analyzed by two blinded plastic surgeons independently. The individual observers scored the photographs for each time point according to the modified Stony-Brook Scar Evaluation Scale (SBSES) and visual analog scale score for photograph (VAS-PH). The VAS-PH consists of parameters of pigmentation, vascularity, acceptability, and observer comfort. Each parameter was given a score of poor or excellent at each time period. The total of each score was given an overall rank of excellent or poor at each period. At 6 months, the overall ranks were compared. The scar was thus classified as excellent or poor.The primary outcome was the measurement of scar improvement as assessed using VSS score and photographic analysis. Secondary outcome includes the improvement in associated symptoms of pain and pruritus as evaluated by VAS scores.

Statistical analysis was done using IBM SPSS version 21. For data with normal distribution, one-way analysis of variance (ANOVA) was applied. Mauchly test was performed in mean data to evaluate the condition of sphericity of data. Using a one-way ANOVA with repeated measures with a Greenhouse-Geisser correction, the differences in mean scores were obtained. For multiple comparisons of groups, least significant difference test (LSD) was used. Interobserver agreement was measured for observational data using kappa score. We employed the Cochran Q test for analysis of photographs as the responses were measured on dichotomous scale (excellent and poor). McNemar test was used to compare pair-wise differences at various time periods for photographic analysis. A statistical P < 0.05 was taken as significant.

 RESULTS



A total of 74 patients were included in the study, of which 52 completed the 6-month follow-up [Figure 1]. There were 35 (67%) males and 17 (33%) females. The mean age of patients was 28 years. Seventy-five percent patients belonged to the age group from 21 to 30. Most of the subjects were Fitzpatrick skin types IV and V (81%). The most common area of involvement was the forehead with 17 patients (33%), followed by cheek with 12 patients (23%) and nose with 10 patients (19%). Other areas such as chin, infraorbital region, and temple account for 13 (25%).{Figure 1}

All 74 patients enrolled in the study underwent randomization using computer generated random numbers and allocated to three distinct groups. Finally, there were 16 patients in Group A, 18 in Group B, and 18 in Group C [Figure 2].{Figure 2}

Scar analysis by the Vancouver scar scale

The VSS scores decreased over the period of observation in all the three groups [Figure 3]. The decrease was statistically significant in the initial 3 months in all the three groups. The scores fell only marginally in the time period from 3 to 6 months. Comparing the scores across the three groups, at similar time points, the difference in scores was significantly better at 1 month favoring Group A. This implied that patients in the silicone only group (Group A) benefit earlier compared to Group B (P = 0.02) and Group C (P = 0.001). [Figure 4]{Figure 3}{Figure 4}

Pain and pruritus

The visual analog scale for pain (VAS pain) was significantly reduced in 6 months in all patients except one. No patient complained of pruritus at the end of 3 months. Lower scores were recorded with coconut oil (Group B) [Figure 5] and [Figure 6].{Figure 5}{Figure 6}

Photographic analysis

According to the analysis of photographs by first independent blind observer, excellent improvement was seen in 42 and poor outcome in 10 patients. For the second blind independent observer, 44 patients showed excellent improvement and eight patients showed poor response in scar modulation (results according to VAS-PH). The VAS-PH by observer one was found to be significant at 2 weeks to 1 month (P = 0.008), 1 month to 3 months (P < 0.001), and 3 months to 6 months (P = 0.031). The VAS-PH by observer two was found to be significant at 1 month to 3 months (P < 0.001) and 3 months to 6 months (P = 0.031).

On analysis of individual groups in SBSES, it was found that all values in the three groups were homogeneous. One-way ANOVA for repeated measurements was employed for statistical analysis. For SBSES score by observer one, the values were found to be nonsignificant for 2 weeks to 1 month and 3 months to 6 months for all the three groups. The value for 1 month to 3 months was found to be significant (P = 0.015) for Group A, (P < 0.001) for Group B, and (P = 0.004) for Group C. For SBSES score by observer two, the values were found to be nonsignificant for 2 weeks to 1 month for all the three groups. The value for 1 month to 3 months was found to be significant for Group A (P < 0.001), for Group B (P = 0.002), and for Group C (P = 0.044). The value for 3 months to 6 months was found to be significant for Group A (P = 0.045), for Group B (P = 0.011), and for Group C (P = 0.023) [Figure 7] and [Figure 8].{Figure 7}{Figure 8}

There were a total of 74 patients enrolled, of which 52 completed the 6-month follow-up with the required treatment protocols. There were no complications noted while using the prescribed preparations. It has also been seen that all patients in the three groups have significant improvement in scar qualities at the end of 6 months. The VSS score of Group A (silicone only) was significant at 1 month and 3 months compared to at 6 months. This showed that topical silicone gel was effective in reducing the unwanted scar properties of hyperpigmentation and vascularity was better compared to coconut oil in 1 month and 3 months. The VSS score has improved in all the patients after 3 months. The mean Vancouver score at 2 weeks, 1 month, 3 months, and 6 months was lower in Group A in comparison to Group B and C. This clearly shows that the application of silicone topical gel twice daily has better effects in scar properties. On multiple comparisons using LSD method, the difference in Vancouver score between A and B and A and C at 1 month was found to be significant with P values of 0.020 and 0.001, respectively, whereas the difference between B and C at 1 month was found to be nonsignificant. The VAS score for pruritus improved in all the patients after the second visit − Group A (9/16), Group B (12/18), and Group C (13/18). The mean VAS pruritus score at 2 weeks, 1 month, 3 months, and 24 weeks was lower in Group B in comparison to Group A and C at 2 weeks and 1 month. This gives the impression that coconut oil is better in decreasing the symptom of pruritus far earlier than silicone gel. This may be attributable to antipruritic properties of lauric acid and palmitic acid in coconut oil.[8],[9],[10] Hence, null hypothesis was proved false in initial period of 3 months [Figure 9],[Figure 10],[Figure 11].{Figure 9}{Figure 10}{Figure 11}

 DISCUSSION



Silicone-based products are the gold standard in management of scar management.[14],[15] Topical silicone gel was recommended as the first-line material to be used to prevent scar hypertrophy and keloids by a convention of international multidisciplinary group comprising 24 experts analyzing recent 20 clinical studies in scar management. This group who conducted the study consisted of various professionals from diverse medical and non medical groups.[16] It is presently a safe product. It does not cause any side effects or systemic toxicity even in a very large quantity.[17],[18] The topical gel has the same efficacy as the silicone gel sheeting as demonstrated by Karagoz et al. In their trial on 45 patients with a follow-up of 6 months and analysis with VSS scores, it was demonstrated that silicone products were more effective in reducing unwanted scar properties.[19] Topical silicone gel is transparent, semipermeable, nontoxic, and easily applicable material and is a very suitable medium for topical application over exposed areas such as face and arms. It is more patient friendly than silicone gel sheeting. Hence, more patient compliance is seen during therapy as demonstrated in 2007 by Chernoff et al.[20] In a more recent work by Stewart et al., on two cohorts of 36 patients with recently healed scar of less than 6 months and older scars of 6 months to 2 years with 16 weeks follow-up was evaluated. It was found from serial photographs from 4 to 16 weeks that there was statistically significant improvement in overall scar qualities and decrease in scar length and vascularity. They also concluded that silicone topical gel is effective in improving the cosmetic appearance of hypertrophic scars up to 2 years. It is similar to our data of 52 patients with 44 (85%) showing marked improvement in scar quality with overall excellent outcome. The improvements shown are first seen in the silicone only group at 1 month and subsequent improving patterns in 6 months.[21] The study conducted by Goldberg on the efficacy and safety of topical silicone gel for early scar management reveals that there were no adverse effects of the product. This study involving 15 subjects with postsurgical scar revealed that there was significant difference for vascularization, thickness, and pigmentation. Significant differences for pliability and height began by 1 month, vascularity by 2 months, and hyperpigmentation by 3 months were found. During the period of 3 months of follow-up, an overall 84.6% subjects found excellent results with twice daily use. This is very similar to our study with no side effects and near similar improvements in Group A patients with twice daily application of topical silicone gel.[22] In comparing the efficacy of the use of topical silicone in modulation of hypertrophic scars and keloids, Westra and Niessen performed a multicentric study involving 224 patients. It was found that regardless of the age of the scar, there were significant improvement in color, thickness, and elasticity of scars which is consistent with our results.[23] Van der Wal et al. demonstrated in 2010 that topical silicone gel is better tolerated and more users friendly. The study was conducted in 46 scars on 23 patients and showed statically significant improvement itching, pruritus and roughness (P=0.012 at 3 months), with overall improvement in scar properties at 3 months.[24]

The safety and efficacy of topical silicone gel was studied by Medhi et al. in 2013.[25] This study used the VSS score for evaluation. The study was conducted on postsurgical scars. In their 36 patients, there was 91% improvement of hyperpigmentation over 2 months (P = 0.0313). Vascularity and pliability were reduced over 3 months (P = 0.0313 for both). In another larger group study by Sepehrmanesh in 1522 patients over 22 months and 66 doctors, from 70% to 84.2% physicians and from 69.8% to 85.1% patients recorded a positive, good, or very good outcome in color, pliability, height, and associated symptoms of pain and pruritus. In this very large study group, approximately 98% of physicians and patients rated tolerability of the topical silicone gel.[26]The strengths of this study are randomized controlled study, tools used for study are well established and objective, objective analysis by blinded experts, and reasonable follow-up period. The weaknesses of the present study are small sample size, single institution study, primary investigator could not be blinded, and one group can be included without any intervention to modulate scar.

 CONCLUSION



Our study highlighted the usefulness of topical silicone gel in modulating facial scars. Topical silicone gel is superior to gel sheet on mobile areas and face due to better retention. It works earlier than coconut oil in reducing vascularity and pliability at 1 month and hyperpigmentation at 3 months. At 3 months of use, the results are comparable for both the materials. Coconut oil was found to have better antipruritic effect at 1 month of use compared to topical silicone gel. It was also found that the scar modulating properties of both the materials was statistically significant over the period of time up to 3 months. Topical silicone gel is a superior product for initial management of scar compared to coconut oil, especially up to 3 months after surgery. Switching over to coconut oil after 3 months of silicone use may be just as good. If so, this might be cheaper and yield similar results at the end of 6 months. The use of scar modulating medications after 3 months requires further analysis.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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